The Delano Report
Enhancement Methods for Bodies & Minds
Posts tagged FDA
FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!”
Feb 2nd
In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!
We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.
The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:
Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
- The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”
We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.
This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.
The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits.
Last year we ran a two-part series on the current status of federal and state law—and FDA jurisdiction—and how it affects integrative treatments (part one and part two).
The Centeno-Schultz Clinic takes your blood, puts it into a centrifuge machine that separates the stem cells, and a doctor puts them back in your body where there is damaged tissue. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s blood from his or her own body.
The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview.
However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx clinic.
Despite this policy, FDA has been attacking the clinic for the past four years. They have tried injunctions and demanded inspections in their attempts to make the company bend; this court battle is merely the latest salvo.
The primary role of adult stem cells in a living organism is to maintain and repair the tissue in which they are found. The hard part has been to get enough of them. But new technology is giving doctors the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments. Blood, fat, or tissue is withdrawn from the patient, stem cells are obtained using one of these new processes, and the cells are injected back into the patient where they can repair the patient’s tissue.
Gov. Rick Perry received this kind of stem cell therapy. We and others noted that the governor’s defense of freedom of healthcare choice when it came to his own treatment was starkly at odds with his directive to administer HPV vaccines to young girls against their own (and their parents’) wishes. It’s also at odds with his support for some of the most egregious witch-hunters on the Texas State Medical Board, which he appoints.
Behind Perry’s blatant inconsistency and the latest FDA attempted power grab lies the same problem: a medical system run by special interests under the leadership of the US government, the same government that is supposed to represent “we the people.”
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FDA Claims Walnuts to be Illegal Drugs | Government Lunacy at its Best
Jan 5th
© Natural Society
Well the Food and Drug Administration has really made a name for themselves this time. In response to claims by a company named Diamond Foods that walnuts possess health benefits, the FDA sent the company a letter informing them of their wrongdoing. What did Diamond Foods do wrong? According to the FDA, claims made by Diamond Foods that omega-3′s found in walnuts produce health benefits make their walnuts “drugs”. As far as the FDA is concerned, these “drugs” can not be legally marketed in the United States without an approved new drug application.
FDA Actions Portray Government Lunacy at its Best
It seems bureaucratic tyranny is really taking shape in America. Despite 35 peer-reviewed published papers showing that walnuts improve vascular health and promote heart function being held in the US National Library of Medicine database,the FDA refuses to allow Diamond Foods to make such claims. The evidence revolving around the benefits of walnuts evidently must be authorized by the FDA before those benefits can even be marketed. A letter sent to the company from the FDA states:
“We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.”
The FDA goes on to say that the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.”
All the while, the FDA is more than happy to allow marketing of chemical-laden, diabetes-inducing foods such as Apple Jacks or Fruit Loops, often targeted at young children. Not only that, but they would much rather the population ‘treat’ their problems with harmful pharmaceuticals rather than with a healthy diet. The government’s actions against natural solutions are sickening to say the least, and saying that walnuts or pomegranates are drugs is an outright false claim. But why are they even making these crazy statements?
The truth is that the pharmaceutical industry, multi-national corporations, and government officials all have both indiscrete and blatant financial ties. Junk food manufacturers heavily lobby the federal government for favorable treatment in order to vacuum in greater profits. In response to the ingestion of massive amounts of junk foods, your body responds so negatively that various health-complications surface, causing you to search for a solution. It just so happens that the pharmaceutical industry has been pushing ‘solutions’ on you for years through mass advertising, making drug ingestion and medical devices the norm instead of healthy alternatives. As far as the government is concerned, there is absolutely no reason for you to live a healthy lifestyle, since many of the government officials would be losing out on a great sum of money.
The FDA simply does not have your best interest at heart. This kind of action truly reflects government lunacy at its best.
Mike Barrett
Natural Society
Tue, 03 Jan 2012 15:08 CST
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Synopsis: Free To Choose Medicine
Apr 30th
Faster access to new drugs can save countless lives and end needless suffering
Deaths from an approved drug become a top story for the nightly news and can lead to Congressional inquiries. Avoiding such negative publicity is the overriding goal of the Food and Drug Administration (FDA). The resulting extreme tunnel focus on safety causes delayed access to innovative drugs, which in turn causes millions of people to suffer and many to die needlessly.
When drug development, testing, and market access to drugs are viewed as a system, it is clear the appropriate system goal should be better drugs, sooner, at lower cost. However, “sooner, at lower cost” is ignored by FDA while it demands ever more testing. Today, a pharmaceutical company spends ten years in clinical testing for a new drug in hope of securing FDA approval. The total cost of an approved drug is about a billion dollars.
The nightly news misses the fact that FDA itself is the bottleneck in the system and fails to report that the result is an enormous invisible graveyard of those who were, are, and will be denied access to new drugs.
Consumer choice would break FDA’s monopoly on access to new drugs. That is the way to turn this problem into an opportunity. The core idea, which should appeal to Republicans, Democrats, and Independents alike, is that we need to be free to make our own informed decisions about whether to use not-yet-FDA-approved therapeutic drugs – that is, new drugs that have successfully passed safety trials, generated preliminary efficacy data, and may offer us the opportunity to improve our health or even save our life. I call this “Free To Choose Medicine.”
Consider how Free To Choose Medicine would have helped those with advanced prostate cancer, which kills 30,000 men every year. Many of those patients literally marched to Washington to rally against FDA’s excruciatingly slow process to approve Provenge, a strikingly innovative cancer vaccine that triggers the body’s natural immune defenses. Patient advocacy groups called for immediate access to Provenge. One memorable advertisement by the advocacy groups was headlined, “Dysfunction at the FDA: Prostate Cancer Victims Face Needless Suffering and Premature Death.”
FDA, with its habitual arrogance and seeming invincibility, is accustomed to ignoring the voices of patients, and it ignored, for many years, the demands of these men.
FDA Will Never Reform Itself
Henry Miller, M.D., a physician, molecular biologist, and public policy analyst who formerly held high-level positions within FDA, gives us his first-hand account of FDA pressures and incentives:
In the early 1980s, when I headed the team at FDA that was reviewing the NDA [New Drug Application] for recombinant human insulin … we were ready to recommend approval a mere four months after the application was submitted. … With quintessential bureaucratic reasoning, my supervisor refused to sign off on the approval – even though he agreed that the data provided compelling evidence of the drug’s safety and effectiveness. “If anything goes wrong,” he argued, “think how bad it will look that we approved the drug so quickly.”1
Dr. Miller’s devastating account of FDA decision-making is Exhibit One for the case that FDA is a dysfunctional system. The consensus opinion of economists who have studied the impact of the steady trend of increasing FDA demands for ever-more expensive and time-consuming clinical trials is that the cost to society has far exceeded the benefit. (See www.fdareview.org.)
A system that involves people is ineffective when incentives are misaligned with goals. Consider, for example, FDA’s “compassionate use” program. This is a program for people who have a life-threatening illness and for whom approved drugs are of little use. The more promising a new developmental drug is and the more serious an illness is, the more motivated patients are to gain access via compassionate use and avoid clinical trials. But there is little incentive for FDA to advertise or expand this program, since it competes with FDA’s primary motive, which is to encourage patients to enroll in clinical trials.
What FDA does want is for the public to accept without question that FDA’s role is to provide “safe and effective drugs.” But no drug is 100 percent safe. Even aspirin can lead, especially in elderly people, to hospitalization and death due to gastrointestinal bleeding and perforation. The simplistic slogan of safe and effective drugs diverts attention away from the basic tradeoff issue facing FDA: More extensive and hugely expensive testing may reduce the probability of unanticipated adverse side effects from an approved drug, but at the same time also greatly increases drug costs to consumers and, most importantly, causes suffering and premature deaths from delayed access. That’s the unavoidable tradeoff situation that is better handled by Free To Choose Medicine.
Dual Tracking
My proposal for Free to Choose Medicine is illustrated in Figure 1.
Figure 1 Dual Tracking
On one track, a new drug continues with conventional FDA clinical trials with the goal of securing FDA approval. On a new, separate track – the Free To Choose Track, which is independent of FDA – patients advised by their doctors make informed decisions to contract with a drug developer to buy a not-yet-approved drug. The drug developer would need to elect to place the drug on the Free To Choose Track, and that drug must have passed the midpoint of its Phase II testing so there would be an early indication of risk and effectiveness. Patients who opt for the Free To Choose Track could gain quicker access to new drugs – by five years or so – compared to waiting for possible FDA approval.
Instead of the current one-size-fits-all regulatory straitjacket that assumes everyone is equally risk-averse, patients could express their own unique preferences for risk, guided by their doctors’ and their own judgments about pain, the limited ability to work or perform daily chores, and the opportunity for health improvement – decisions only they can make. Patients could elect to use only approved drugs, which are very safe. No one is forced to accept less-safe drugs.
Creating a Tradeoff Evaluation Database
For us to be able to judge if the benefit from a new drug exceeds the benefit from an approved drug and is worth the risk – i.e., for us to be informed well enough to be able to evaluate the tradeoff – we and our doctors would need relevant, up-to-date information. Under my proposal, that information would be accessible on the Internet through a Tradeoff Evaluation Database (TED), as shown in Figure 2.
Figure 2 Tradeoff Evaluation Database (TED)
Legislation to implement Dual Tracking should specify that participation in the Free To Choose Track requires not only that doctors input treatment results to TED, but also that patients permit doctors to transmit the patient’s genetic and biomarker information to TED. Over time, this would create a treasure trove of public data that would greatly benefit pharmaceutical research.
Drug developers would be unlikely to make new drugs in clinical testing available through a Free To Choose Track if they could be held liable for all side effects even if they were not negligent in developing, testing, or manufacturing. Consequently, as part of a Free To Choose Medicine Act, Congress would adopt legislation permitting patients to waive their right to sue drug developers under strict product liability as long as developers do not provide false or misleading information.
At no charge, a government-operated TED would provide the information needed to make informed decisions about what is in patients’ best interests. Private-sector companies (e.g., Google, Microsoft, IBM, and such) would have a profit incentive to sell customized “consumer reports” that would further help patients and doctors. Consumer reports could pinpoint subsets of patients who are most and least likely to benefit, forecast the probability of FDA approval, and provide head-to-head comparisons of Free to Choose drugs against relevant FDA-approved drugs.2
TED would transfer knowledge (and power) to doctors and patients. This could disrupt enrollment in those clinical trials where knowledgeable doctors judge the drug to be tested as superior to approved treatments. The proper response from FDA should be to develop more innovative testing procedures that avoid unethical clinical trials and give top priority to today’s patient needs.3
Conditional Approval
Before and during Phase III testing, TED would make public a vast amount of clinical trial and observational data. Some drugs would show strikingly effective treatment results compared to FDA-approved drugs. Then, many knowledgeable doctors may object to enrolling their patients in Phase III randomized control trials on the ethical grounds of not wanting to subject their patients to the risk of receiving an inferior drug or useless placebo.
In this new environment, the formerly invisible costs of suffering and death due to delayed access to new drugs would become much more visible. Heightened public awareness of the opportunity costs would make things increasingly uncomfortable for FDA. Contributing to this pressure would be the lack of insurance coverage for the new drugs that are in high demand via the Free To Choose Track when they appear to be delivering significant health improvements.
Most private health insurance contracts cover only FDA-approved drugs. Lack of FDA approval could keep people with less financial means from obtaining the life-improving or life-saving drugs accessible via the Free To Choose Track. This is not a situation Americans would want, and we would pressure FDA to get more engaged with the needs of all patients.
One way to help FDA respond is for the Free To Choose Medicine Act to allow the agency to grant conditional approval for a new drug based on a combination of results from clinical trials and Free To Choose Track use. To maintain conditional approval, the developer would have to agree to complete Phase III trials and obtain conventional FDA approval within a reasonable time.
Change Attuned to the Future
There already is a segment of the medical marketplace where consumer choice is much less restricted. Off-label drug use occurs when doctors write prescriptions to be used in ways for which the drugs were not FDA-approved. A leading researcher in the treatment of breast cancer noted, “If I had to use drugs for their approved uses only, half my patients would be dead.”4
Off-label drug use is a window into an environment where things happen to best serve today’s patients. The widely acknowledged success of unregulated, off-label prescription use is consistent with expectations that doctors would actively use TED in the future for the benefit of their patients.
We need a drugs-to-patients system that can adapt to a future with an accelerated pace of medical innovation, coupled to the widespread advancement of personalized medicine. Diagnostic testing will match patients according to their genetic makeup with drugs that are much more likely to work and to have fewer adverse side effects. In this environment, early access becomes more and more beneficial over time. Dual Tracking would accommodate early access as well as dramatically speed up the delivery of medical advancements.
With the Free To Choose Track, a new drug showing strongly positive results would lead to a surge in use by patients with diverse characteristics that more accurately reflect the general patient population of drug users than do the patients enrolled in FDA’s randomized controlled trials. Consequently, upon receiving FDA approval, drugs would have a more reliable safety profile if they were used by patients on the Free To Choose Track. Consumers who choose to use only approved drugs would benefit from the voluntary decisions of those willing to accept more risk in exchange for early access.
A quite plausible forecast is that prescription drug prices would drop substantially after feedback about how well patients do when they opt to make their own choices for approved versus not-yet-approved drugs. Such feedback would be expected to compel FDA to radically streamline its testing process, thereby providing a major reduction in regulatory costs for drug developers.
Conclusion
To sum it all up, Free To Choose Medicine would provide faster access to new drugs, save countless lives, and end needless suffering. It would put us on a competitive path that both lowers prescription drug prices and advances innovation – exactly opposite of a price control path to lower drug prices that some health care reform advocates are pushing. Their option would seriously reduce long-term innovation.
Passage of a Free To Choose Medicine Act would be a defining moment for America – a directional change from today’s trend of increasing litigation and regulation – a stake in the ground that control of medical decisions belongs, first and foremost, with individual patients and their doctors, and not the government. It deserves a chance.
Bartley J. Madden is the author of Free To Choose Medicine.
Endnotes
1. Henry I. Miller, To America’s Health: A Proposal to Reform the Food and Drug Administration (Stanford, CA: Hoover Institution Press, 2000), 41-42.
2. Alexander T. Tabarrok, “Bringing the Consumer Revolution to the FDA,” Independent Institute, Commentary, April 25, 2005.
3. “Types of Randomized Controlled Trials,” Chapter 2 in Alejandro R. Jadad and Murray W. Enkin, Randomized Controlled Trials (Malden, MA: Blackwell Publishing, 2007, 2d edition), 12-28. Scott Gottlieb, “Improving Access to Life-Saving Medicines through Modernization of the Regulatory Review Process,” presentation to the Food and Drug Law Institute’s Colloquium on Access to Unapproved Drugs, February 27, 2007 (unpublished).
4. Dr. Larry Norton quoted in Robert M. Goldberg, “Breaking Up the FDA’s Medical Information Monopoly,” Regulation 18, No. 2 (1995), 40-52.
Source: http://www.heartland.org/ftcm/synopsis.html
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San Francisco Rainwater Radiation 181 Times Above US Drinking Water Standard
Apr 6th
Radiation from Japan rained on Berkeley, California, during recent storms at levels that exceeded drinking water standards by 181 times. A rooftop water monitoring program managed by the University of California at Berkeley’s Department of Nuclear Engineering detected substantial spikes in rain-borne iodine-131 during those torrential downpours. The levels exceeded federal drinking water thresholds, known as Maximum Contaminant Levels — or MCLs — by as much as 181 times or 18,100%. Iodine-131 is one of the most cancer-causing toxic radioactive isotopes spewed when nuclear power plants are in meltdown. It is being ingested by cows, which have begun passing it through into their milk and radioactivity has been detected. [Multiple Sources]
Specific Scientific Data
The iodine-131 level in the rainwater sample taken on the roof of Etcheverry Hall on the campus of UC Berkeley on March 23rd, 2011, from 9:06-18:00hrs Pacific Daylight Time (PDT) states radioactivity levels at 20.1 Becquerels per Litre (Bq/L) = 543 PicoCuries per Litre (pCi/L). The federal maximum level of iodine-131 allowed in drinking water is 3 pCi/L or 0.111 Becquerels per Litre. The sample exceeded the federal guidelines for drinking water by 181 times. The UC Berkeley researchers also discovered trace levels of iodine-131 and other radioactive isotopes, believed to have originated in Fukushima, in commercially available milk and in a local stream within California. [UC Berkeley]
No Official Data Yet
Three weeks after the Fukushima nuclear power plant began spewing radiation into the world’s air, the US government has still not published any official data on nuclear fallout from the Fukushima meltdown. The amount of iodine-131 or other radioactive elements that have fallen as precipitation or made their way into milk supplies or drinking water has not yet been fully revealed. Scientists say an absence of federal data on the issue is hampering efforts to develop strategies for preventing radioactive isotopes from contaminating the nation’s food and water. [The Bay Citizen, San Francisco]
Rising Risks
Fukushima radiation is blanketing most of the United States and Canada according to the data and visuals published regularly by the The Norwegian Institute of Air Research. The risks of that radiation falling with rain, have been downplayed by US government officials and others, who say its impacts are so fleeting and minor so as to be negligible. Nonetheless, radiation falling with rain can cover grass that is eaten by cows and other animals. It can also fall on food crops or contaminate reservoirs that are used for irrigation or drinking water. [Norwegian Institute of Air Research or NILU]
Food and Water Watch
Food and Water Watch — the nonprofit Non-Governmental Organisation (NGO) based in Washington, DC — sent a letter to President Barack Obama and members of his cabinet and Congress a few days ago urging the US federal government to improve its monitoring of radiation in agricultural land and food in the wake of the Japanese tragedy. The letter from “Food and Water Watch” states: “The three agencies that monitor almost all of the food Americans eat … have insisted that the US food supply is safe . . . the agencies, however, have done very little to detail specific ways in which they are responding to the threat of radiation in food.”
EPA and FDA
The federal Environmental Protection Agency (EPA) states in its April 3rd advisory, “As the Nuclear Regulatory Commission has said, we do not expect to see radiation at harmful levels reaching the US from damaged Japanese nuclear power plants.” The US Food and Drug Administration (FDA), which regulates food safety, has referred questions about potential milk contamination to the EPA, which is taking the lead on testing dairy products for radiation. Early last week, the EPA said it expected to release results of tests for radioactivity in rain and snow within a day or so. Just before the weekend, three days after making that pledge, EPA officials repeated the same statement and said the data would likely be released over the weekend or early this week. So far that data set has not been released. [EPA]
Conclusion
Potentially cancer-causing radiation from Fukushima has been encircling the world, traveling quickly on jet streams high in the atmosphere and falling with precipitation like rain and snow. It is already being detected in air, water and milk in some parts of the United States by local and state agencies. For example, San Francisco rain water radiation levels exceeded federal drinking water thresholds by as much as 181 times recently. A radioactive isotope, such as iodine-131, is supposed to have a half-life of eight days. This is inferred to mean that it breaks down quickly, and it quickly dissipates in the environment. However, the 8 day half-life can be a misnomer because radioactive iodine can really persist in the environment for many months and has a 100 day biological half-life once inside the human body.
Source: http://www.marketoracle.co.uk/Article27360.html
By: DK_Matai
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The Chemicals In Your Cosmetics
Feb 25th
Sodium lauryl sulfate is an effective degreaser used to clean oil stains from the floor of my mechanic’s repair shop; what’s it doing in my toothpaste and my daughter’s bubble bath? And, why is the long-known carcinogen nitrosamine, banned in Canada and the European Union, still a common ingredient in my mascara, concealer, sunless tanning lotion and baby shampoo?
The simple answer is that the U.S. Food and Drug Administration still doesn’t bother to regulate anything it dismisses as cosmetics — any products used topically — despite the growing science showing how easily poisons and pollutants can be absorbed through the skin. Since the 1930s, the only thing the FDA regulates is the accuracy of the labeling on cosmetics.
As long as manufacturers list in gory detail the witches’ brew of industrial chemicals, heavy metals, and toxic substances they blend into your eye cream or face wash, they are free to dump whatever they want into your epidermis.
As consumers, we are left to defend ourselves armed only with unintelligible ingredient labels and confusing news reports about what parts per billion of something can cause cancer or Alzheimer’s. Americans are taking their bodies on a magical mystery tour full of chemicals and heavy metal toxins by way of basic grooming habits.
Just a little Googling reveals that every day we are exposed through personal care products to more than 10,000 nasty chemicals banned elsewhere in the world. Everything from lip balm to hand lotion is filled with stuff we wouldn’t dream of putting in our stomachs. Instead, we eagerly spread it over the largest organ of the body — ensuring effective absorption and exposure to a daily dose of illness-inducing and cancer-causing garbage. The american medicine cabinet has become a virtual love canal of hidden industrial waste that wouldn’t be allowed anywhere else.
For example, the Environmental Protection Agency requires workers to wear protective gloves, clothing, and goggles when handling chemicals like Diazolidinyl Urea and Propylene Glycol when they manufacture your favorite antiperspirant. The EPA warns workers against skin contact with these chemicals because they are known to cause brain, liver, and kidney abnormalities — in concentrations lower than those found in off-the-shelf stick deodorants. By contrast, you are not even given a fair warning by the deodorant industry as it encourages you to apply these very same poisons to your naked underarms every morning.
Okay, so according to Washington it’s every woman for herself, but ever try to read the ingredients of your shampoo? I mean the ingredients that are actually listed? Good luck even pronouncing isobutylparaben. And if “fragrance” is involved you’ll never actually get the straight story. Fragrance is protected as a trade secret and up to 200 suspect ingredients can be buried in there with no call-out.
In a recent Congressional hearing the head of the FDA’s Center for Food Safety and Applied Nutrition, Stephen Sundlof, waved the white flag when he said, “The law as it is currently written allows virtually anything to be incorporated into a cosmetic.” This lack of oversight means that consumers actually know very little about what makes up their make-up. And there is little rigor to the enforcement of existing policies: only nine out of tens of thousands of chemicals have been banned in the U.S., compared to 11,000 so far in the E.U.. Even more alarming is the fact that only 11 percent of ingredients used by Americans in personal care products have even been reviewed for safety — by anyone.
So, what have the Europeans and Canadians figured out that we have not? For one, their governments don’t rely on a voluntary reporting system to monitor product safety. Incidents — from adverse reactions to longitudinal health surveys — are made public by law. Under decades-old U.S. law, cosmetics companies are not required to publicly submit information on the safety of their products so, surprise, they don’t. And the toothless FDA relies almost solely on the Cosmetic Ingredient Review (CIR), the industry’s self-policing safety panel, for its product safety data. European regulators do their own safety research and reporting.
While the poets may consider your body a wonderland, the truth is it’s more likely a wasteland of built-up toxins that would earn perpetrators federal jail time if they dumped it into any canal other than the alimentary.
What we need is a green movement for the human body. Improving consumer protections against “body dumping” must start with the FDA. Fortunately, even with a regulation-averse Congress, much of the FDA’s powers are interpreted internally. There are numerous administrative steps the FDA can take without Congress butting in — if it so motivated by public alarm. You can contact your regional FDA office and make some noise. Several good organizations under the banner of the Campaign for Safe Cosmetics — including the Environmental Working Group and Health Care Without Harm — have been banging the drum in Washington, but they need our help to be effective.
It seems our city sewers have more protections than we do. As a creative alternative, perhaps we could declare ourselves micro-dumps and ask for protections under the EPA. Or we might seek relief from broader protections granted to us under the Occupational Safety and Health Organization (OSHA). Hazmat-clad technicians could scan our ditty bags for offending lipstick and hand creams.
One has to wonder if all this would be different if men wore makeup and a tad more product in their hair.
Source: The Huffington Post, Estelle Hayes is a Silicon Valley journalist and blogger.
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